The upcoming ASH Annual Meeting will feature crucial updates from clinical trials involving daratumumab, selinexor, and asciminib, offering insights into the treatment of multiple myeloma and chronic myeloid leukemia. These data updates promise to refine treatment strategies and improve patient outcomes in these hematologic malignancies.
Daratumumab in Smoldering Multiple Myeloma
Muhamed Baljevic, MD, FACP, from Vanderbilt-Ingram Cancer Center, highlighted the importance of the randomized, phase 3 AQUILA study (NCT03301220), which investigates daratumumab monotherapy versus active monitoring in patients with high-risk smoldering multiple myeloma. The long-term follow-up results from this study are eagerly awaited, as they are expected to inform future management strategies for this patient population. According to Dr. Baljevic, these data are crucial for understanding the efficacy of single-agent daratumumab in delaying disease progression.
Selinexor, Pomalidomide, and Dexamethasone in Multiple Myeloma
Dr. Baljevic will also present updated results from the phase 1b/2 STOMP trial (NCT02343042). This dataset will include cohorts treated with weekly doses of 40 mg or 60 mg of selinexor in combination with pomalidomide and dexamethasone. The presentation at ASH will focus on the 96-week data, providing critical information regarding the efficacy and safety of this combination therapy.
Asciminib in Chronic Myeloid Leukemia
Jorge Cortes, MD, director of the Georgia Cancer Center at Augusta University, previewed the 96-week data update from the phase 3 ASC4FIRST trial (NCT04971226), which evaluates asciminib in newly diagnosed chronic myeloid leukemia in chronic phase (CML-CP). This update will compare the efficacy and safety of asciminib with investigator-selected TKIs as frontline therapy.
Asciminib received accelerated approval from the FDA on October 29, 2024, based on data from the ASC4FIRST trial. The data showed that patients treated with asciminib (n = 201) achieved a 48-week major molecular response (MMR) rate of 68% (95% CI, 61%-74%) compared to 49% (95% CI, 42%-56%) in those treated with investigator’s choice of TKI (n = 204). The difference was statistically significant (19%; 95% CI, 10%-28%; P < .001). TKIs included imatinib, nilotinib, dasatinib, or bosutinib.
Dr. Cortes emphasized that this update will provide insights into the long-term efficacy and safety profile of asciminib as a first-line therapy for newly diagnosed CML-CP. The FDA approval of asciminib marks a significant advancement in improving patient outcomes and potential cure rates for this disease.
